(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that any deficiency of the ethicon product endoloop or pds suture caused and/or contributed to the adverse events described in the article? citation: can j surg, vol.55, no.1, february 2012.[(b)(4)-safavi 2012 (3).Pdf].
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It was reported in journal article title: endoloop versus endostapler closure of the appendiceal stump in pediatric laparoscopic appendectomy.Authors : arash safavi, md, monica langer, md, erik d.Skarsgard, md.Doi: 10.1503/(b)(4).Citation: can j surg, vol.55, no.1, february 2012.The aim of this study was to compare infectious outcomes between 2 laparoscopic techniques of appendiceal stump closure: endoloop (el) and endostapler (es).A total of 242 patients underwent la during the study period and had complete data sets abstracted retrospectively from their medical records.The patient were divided into 2 groups: non-perforated appendicitis (npa) n=185, perforated appendicitis (pa) n=57.One surgeon used the es (ethicon endosurgery) in all cases (pa and nonperforated appendicitis [npa]) whereas 2 surgeons routinely used el unless the condition of the appendiceal base favoured use of an es to ensure sealing of healthy tissue.Endoloop stump closure consisted of 2 proximal and 1 distal 2¿0 polydioxanone (pds; ethicon) els, with division of the appendiceal base between the middle and distal el.Surgical site infections (npa (n=2); pa (n=2)) and intra-abdominal abscess formation (npa (n=5); pa (n=6) with the use of el were reported.Intra-abdominal abscess formation (n=5) with the use of endostapler was also reported.In conclusion, this study suggests that preferential use of el for appendiceal stump closure in la is associated with at least equivalent infectious outcomes, as well as cost savings, in comparison to routine use of es.
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